Posted on :
4 Jun, 2018
4 Jun, 2018
Job Title: Manager: Quality Operations
Manage the Quality Operations team in meeting the company’s objectives in terms of Vendor management, Change control management, Pre-launch activities, and supporting other business units with specific projects, while operating in compliance with company standards.
Manages compliance with regards to GxP (GMP, GDP & GLP, etc) * Manages and supports the implementation and maintenance of a Quality Management System (QMS) aligned with or exceeding the requirements stated in the SA Guide to GMP and ISO 13485/9001, cognisant of the company corporate requirements, for: Vendor Compliance, Change Control/Change Requests, Product Launch, Dossier Development (CAMS), QA Due Diligence & by means of relevant SOP’s and Policy review and approval.
Vendor Compliance * Change Control/Change Requests * Manage the CC/CR process, ensuring that SLA’s are maintained, without compromising product availability * Manage the CC/CR log, ensuring follow up and resolution of open CC’s within agreed timelines * Ensure that required data is generated by the manufacturing site and is available for dossier submission * Master Documentation * Product Launch * Dossier Development * Supports Quality Operations Executive SSA/HR/personnel compliance and best practices: Develop cross functional and stakeholder relationships, develop and implement budgets for the Quality Operations functions so that the cost and quality objectives are met.
Salary negotiable depending on experience.
Please email your CV to response “@” mvgrecruitment.co.za or call 0860 100 684 or fax 086 575 0166.